Pricing and distribution of medical diagnostics

ABSTRACT

In one embodiment, a method of pricing a diagnostic test includes receiving data associated with the diagnostic test and setting a price of the diagnostic test. The data associated with the diagnostic test includes an indication of one of a first result of the diagnostic test and a second result of the diagnostic test. The price of the diagnostic test is set based on the indication included in the data associated with the diagnostic test. In another embodiment, a method of pricing a diagnostic test includes receiving data associated with the diagnostic test and charging a first price or a second price for the diagnostic test. The data associated with the diagnostic test includes an indication of one of a first result of the diagnostic test and a second result of the diagnostic test. The first price and/or the second price can be charged based on the indication.

CROSS-REFERENCE TO RELATED APPLICATIONS

This application is a continuation of U.S. patent application Ser. No.12/499,505, filed Jul. 8, 2009, entitled “Pricing and Distribution ofMedical Diagnosis,” which claims priority to and the benefit of U.S.Provisional Patent Application Ser. No. 61/079,272, filed on Jul. 9,2008, entitled “Pricing and Distribution of Medical Diagnostics,” bothof which are incorporated herein by reference in their entireties.

BACKGROUND

The disclosed embodiments relate generally to pricing medicaldiagnostics including, for example, medical diagnostics for determiningwhether a patient has or is likely to develop a disease, or thesuitability of a therapeutic treatment. Methods and apparatus accordingto various embodiments are capable of, for example, pricing a medicaldiagnostic based on value created by the medical diagnostic.

Certain medical diagnostic tests (“diagnostics”) such as moleculardiagnostic tests can be intended to be predictive of the efficacy,safety and/or response of particular therapeutic regimens. The Food andDrug Administration (“FDA”) may, for example, require the availabilityand use of a diagnostic test prior to administration and use of certainpharmaceutical therapies.

Such a requirement or clinical obligation for use of a companiondiagnostic test before starting a drug regime presents a problem fordrug manufacturers that do not currently control (e.g., own) and pricethe diagnostic (or intellectual property related to the diagnostic). Themanufacturer of the diagnostic, for example, in order to maximizeprofit, has an incentive to price the diagnostic very high due to itshigh economic utility and one-time use. The manufacturers and/ordistributors of therapeutic drugs (or other complementary products ortherapeutic treatments) have an opposing pricing viewpoint. Suchmanufacturers and/or distributors would prefer that the diagnostic bepriced low, such that more individuals can be tested and, subsequently,begin a therapeutic treatment utilizing the manufacturer's products.

Additionally, the typical usage profile of a diagnostic is a single useand the typical usage profile of a therapeutic treatment is ongoing use.Due to these different usage profiles, the combined economic value ofthe diagnostic and the therapeutic treatment may be greatest if thediagnostic has a low price. Thus, the high price of some diagnostics andlow disease rates of the diseases for which the diagnostics test canmake broad screening with diagnostics uneconomical even if thediagnostic is highly accurate.

Methods of pricing diagnostics are known. For example, one such methodincludes the price of a medical diagnostic in the average price of acomprehensive treatment of a condition indicated by the diagnostic.Thus, an individual who is tested with the medical diagnostic for amedical condition and undergoes a treatment for the medical conditionwill be charged the same price as other individuals receiving thediagnostic and treatment.

Some known pricing methods allow a user to pay a fixed cost of a medicaldiagnostic or medical treatment over a period of time. For example, apatient can make monthly payments on the cost of a medical diagnostic ormedical treatment for a number of years to spread the cost of thediagnostic and/or treatment over time.

However, known diagnostic pricing methods fail to provide incentives fordiagnostic manufacturers to price diagnostics such that the combinedmedical and/or economic value between a diagnostic manufacture and drugmanufactures can be advantageously realized. Furthermore, knowndiagnostic pricing methods fail to encourage testing or screening oflarge populations to determine whether certain therapeutic treatmentscan be beneficial to individuals in these populations. Thus, a needexists for improved pricing methods for diagnostics.

SUMMARY

In one embodiment, a method of pricing a diagnostic test includesreceiving data associated with the diagnostic test and setting a priceof the diagnostic test. The data associated with the diagnostic testincludes an indication of one of a first result of the diagnostic testand a second result of the diagnostic test. The price of the diagnostictest is set based on the indication included in the data associated withthe diagnostic test.

In another embodiment, a method of pricing a diagnostic test includesreceiving data associated with the diagnostic test and charging a firstprice or a second price for the diagnostic test. The data associatedwith the diagnostic test includes an indication of one of a first resultof the diagnostic test and a second result of the diagnostic test. Thefirst price is charged if the indication is of the first result. Thesecond price is charged if the indication is of the second result. Thesecond price is greater than the first price.

In another embodiment, a method of determining a price for a diagnostictest includes receiving data associated with the diagnostic test,calculating a value of the diagnostic test, and determining the pricefor the diagnostic test. The data associated with the diagnostic testincludes an indication of one of a first result of the diagnostic testand a second result of the diagnostic test. The value of the diagnostictest is calculated based on the indication included in data associatedwith the diagnostic test. The price for the diagnostic test isdetermined based on the value of the diagnostic test.

In another embodiment, a method of pricing a diagnostic test includescharging a first price for the diagnostic test, receiving dataassociated with the diagnostic test, and charging one of a second priceand a third price for the diagnostic test. The first price is chargedbefore administration of the diagnostic test. The data associated withthe diagnostic test includes an indication of one of a first result ofthe diagnostic test and a second result of the diagnostic test. Thesecond price is charged if the indication is of the first result, andthe third price is charged if the indication is of the second result.

In another embodiment, a method of distributing a diagnostic testincludes, providing a diagnostic test to a first party, receiving dataassociated with a result of the diagnostic test, collecting from thefirst party a first cost, and providing a portion of the first cost to asecond party. The first party effects administration of the diagnostictest. The first cost is based on the result of the diagnostic test.

BRIEF DESCRIPTION OF THE DRAWINGS

FIG. 1 is a flow chart of a process for determining a price of adiagnostic, according to an embodiment.

FIG. 2 is a flow chart of a process for determining a price of adiagnostic, according to another embodiment.

FIG. 3 is a flow chart of a process for determining a price of adiagnostic, according to another embodiment.

FIG. 4. is a flow chart of a process for distributing a diagnostic,according to an embodiment.

FIG. 5 is a system block diagram of a system for pricing a diagnostic,according to an embodiment.

FIG. 6 is a flow chart of a process for performing a diagnostic,according to an embodiment.

FIG. 7 is a flow chart of a process for realizing a multi-part pricingstructure, according to an embodiment.

DETAILED DESCRIPTION

Methods and apparatus according to various embodiments can encourage theuse of potentially beneficial diagnostic tests within clinical settings.For example, these embodiments separately and/or together createmechanisms and systems for logically and analytically transferringportions of the economic value of diagnostic tests among various partiesinvolved in medical diagnosis and treatment. In doing so, methods andapparatus can transform economically unrelated diagnostics andtherapeutics into an integrated optimizing pricing configuration bycreating economic incentives for both the development, production, andmaximum use of such diagnostics. For example, some of the economic value(e.g., revenue from drug sales) generated when a diagnostic indicatesuse of a particular drug will likely be beneficial for an individual canbe transferred from the manufacturer of drug to the manufacturer of thediagnostic test.

Such value transfer can be particularly useful with diagnostics thatscreen for diseases that have a very low probability of occurrence,because the value of diagnostics can be significantly less than economiccosts of the diagnostic for individuals, insurance companies and/or drugmanufacturers. For example, the cost of administering a diagnostic testto screen a large population to determine if a drug will be beneficialto each individual in the population can be prohibitively expensive fora drug manufacturer who does not own the diagnostic (or intellectualproperty related to the diagnostic). If the cost of the diagnostic testis high and the probability or prevalence of the genetic condition beingtested is low, the cost of the diagnostic will often be many timesgreater than revenue from sales of the therapeutic because the drug willbe beneficial for only a small number of individuals in the population.However, if the cost (e.g., cost charged for administration or use) ofthe diagnostic test is low and the diagnostic manufacturer shares in therevenue generated by drug sales, the drug company can afford to screenlarger populations. Additionally, a low-cost diagnostic allowsphysicians to liberally test or screen patients for treatableconditions, suitability of specific drugs, and other medically usefulinformation.

Diagnostic tests as used herein include tests for determining thesuitability of one or more therapeutic treatments for an individual andinclude, for example, molecular diagnostic tests, genetic tests, andother medical tests. A therapeutic treatment can be any method oftreating a medical or physiological condition. For example, atherapeutic treatment can be use of a drug or other therapeuticcompound, a change in lifestyle or diet, physical therapy, and/or genetherapy. Diagnostic tests can be used, for example, to determine whethera person has or is likely to have a disease or disorder; determinewhether a person will or likely will positively react to a particulartherapeutic treatment; determine whether a person will or likely willhave an adverse reaction to a particular therapeutic treatment; and/ordetermine whether a person will or likely will develop a disease ordisorder. Thus, information gained or derived from such diagnostics canhelp to create economic and other benefits resulting from individual, orpopulation-specific guidance to, for example, chose a therapy over notherapy, chose one course of therapy over alternatives, choose acombination of therapies over alternatives, avoid a particular course oftherapy, and/or create lifestyle changes based on results ofdiagnostics.

In one embodiment, the manufacturer of a diagnostic test provides thediagnostic test to the manufacturer of a drug that treats a medicalcondition screened for by the diagnostic test at a low price. Forexample, the diagnostic test can be provided free of charge or for anominal charge. The drug manufacturer can use the diagnostic to screen alarge number of individuals to determine whether a drug will bebeneficial for particular individuals. Because the diagnostic test isprovided for a low price, the drug manufacturer can screen manyindividuals without incurring unmanageable costs. The diagnostic allowsthe drug manufacturer to access a broader market of potential customersfor the drug by demonstrating to the potential customers that the drugwill be beneficial to them, based on results of the diagnostic test. Thedrug manufacturer is able recoup the costs of the diagnostic teststhrough revenue generated by drug sales to individuals who buy the drugbased on the diagnostic test.

After the drug manufacturer has used the diagnostic to determine whethera drug will be beneficial to an individual and the individual purchasesthe drug, the drug manufacturer makes additional payments to themanufacturer of the diagnostic. This allows the diagnostic manufacturerto collect or share in downstream profitability and revenues that resultfrom use of the diagnostic. For example, if a result of a diagnostictest indicates that an individual will benefit from taking a drug for aperiod of time, the drug manufacturer can make recurring payments to themanufacturer of the diagnostic test for the period of time theindividual is taking or using the drug. These payments can be based on,for example, the value generated by the diagnostic test (e.g., therevenue the drug manufacturer will receive from an individual to whomthe diagnostic test was administered).

For example, consider a class of drugs for lipid-lowering therapy in theprevention of coronary heart disease known as statins. These life savingdrugs would appear to be a natural fit for pharmacogenomic diagnostictesting. Yet today, statin response testing is uncommon. An impedimentto statin response testing lies with the multitude of prescriptionchoices for physicians and patients. For example, statin choicesinclude: Fluvastatin, Lovastatin, Mevastatin, Pitavastatin, Pravastatin,Rosuvastatin, Simvastatin, Simvastatin+Ezetimibe, Lovastatin+Niacin, andAtorvastatin+Amlodipine Besylate. Thus, even if diagnostic tests for aparticular group of statin drugs or therapies are readily available, itis not clear which tests a physician should administer. The costs totest all drugs or therapies would be prohibitive, and moreover such atest cost would be wasted if the patient switched to a new therapy ashort time later. Instead, the physician will often prescribe a certainstatin, and if it does not give the intended effect, will switch thepatient to the next choice. A more efficient method, described herein,includes transforming these individual tests, drugs, and/or therapiesinto a consolidated pricing model whereby the patient is tested for alow or nominal cost for all tests. The therapeutic manufacturer thatbenefits from the tests, drugs, and/or therapies (e.g., the therapeuticmanufacturer that sells a drug based on the positive diagnostic test)then effectively pays for the test price because that test generatedbenefit to that particular therapeutic manufacturer.

As used in this specification, the singular forms “a,” “an” and “the”include plural referents unless the context clearly dictates otherwise.Thus, for example, the term “a diagnostic” is intended to mean a singlediagnostic or a combination of diagnostics, “a manufacturer” is intendedto mean one or more manufacturers, or a combination thereof.

FIG. 1 is a flow chart of process 100 for determining a price of adiagnostic, according to an embodiment. Data regarding the results of adiagnostic are received at 110. The data can be any representation orindication of the results of a diagnostic and/or including the resultsof a diagnostic. The data can be, for example, a report including theresults of the diagnostic, or data from the diagnostic that has not beenpreviously analyzed to determine a result of the diagnostic. In someembodiments, the data are digital data such as, for example, a digitalrepresentation of a mass spectrum or assay analysis of a diagnostic. Insome embodiments, the data are a biological sample such as, for example,a blood sample and/or a tissue sample. In some embodiments, the data canbe a report such as, for example, an electronic or paper documentincluding information associated with the diagnostic.

The result of the diagnostic can indicate, for example, that a personhas or is likely to have a disease or disorder; that a person will orlikely will positively react to a particular therapeutic treatment; thata person will or likely will have an adverse reaction to a particulartherapeutic treatment; and/or that a person will or likely will developa disease or disorder. In some embodiments, the result of the diagnosticindicates a first biological state or a second biological state such as,for example, the presence of a disease or the absence of a disease. Insome embodiments, for example, a diagnostic can determine the presenceof cancer in an individual (a first biological state) or the absence ofcancer in the individual (a second biological state).

In some embodiments, the result of a diagnostic indicates the likelihoodof one or more conditions, or an outcome of one or more conditions. Forexample, a diagnostic can indicate that an individual will likelyrespond positively to a therapeutic treatment such as, for example, atreatment period or regime with a particular drug or a gene therapytreatment. In some embodiments, a diagnostic can indicate that anindividual is likely to develop a disease or disorder. In otherembodiments, a diagnostic can indicate that an individual will or likelywill have an adverse reaction to a therapeutic treatment.

A value of the diagnostic is determined at 120 of process 100. The valueof a diagnostic can be, for example, an economic benefit, a non-economicbenefit and/or a combination of economic and non-economic benefits toone or more individuals or entities as described in more detail below.Non-economic benefits include, for example, quality of life, improvedmobility, and/or the ability to enter or re-enter the workforce. Forexample, health attributable to discovery by a screening diagnostic of adisease in early or treatable stages that is subsequently successfullytreated, is a value or benefit to the individual successfully treatedfor the disease.

A value of a diagnostic can be calculated using various methodologies.Any methodology of assigning a value to benefits enabled by a diagnosticmay be used. As described as an example in more detail below, a valuecan be calculated based on the value of a particular result to one ormore interested parties. Also, as described as an example in more detailbelow, a value can be determined based on economic modeling or economicvalue analysis.

In some embodiments, the value is calculated or determined based on aresult of a diagnostic. For example, a result indicating the presence ofa disease in an early or treatable stage can have value and bebeneficial to an individual and an insurance company because the diseasecan be treated with less cost and better results than if the disease wasdiscovered in an advanced stage of the disease. Such a result can alsobe beneficial to drug manufacturer if its drug is used in treating thedisease. A result indicating the absence of a disease, or that aparticular therapeutic treatment will be ineffective, can also havevalue to an individual and an insurance company. Such a result can, forexample, prevent unnecessary expenditure on unnecessary therapeutictreatments. In some embodiments, the value is determined based onmultiple results of one or more diagnostics. In other embodiments, thevalue is predetermined based on expected results of a diagnostic.

In some embodiments, diagnostic value can be ascertained througheconomic value analysis such as, for example cost of illness analysis,cost minimization analysis, cost benefit analysis, cost effectivenessanalysis and/or cost utility analysis. For example, a typicalcost-benefit analysis as described in Dervieux & Bala, “Overview ofPharmacoeconomics of Pharmacogenetics”, Pharmacogenomics (2006);7(8):1175-1204, which is incorporated herein by reference in itsentirety, includes Quality-Adjusted Life Years (“QALY”) calculationsdependent on clinical performance of a genetic test. In suchcalculations, the value of the diagnostic may be ascertained bycomparing two or more healthcare procedures. Cost is calculated inmonetary units and benefits are expressed in physical units, such asside affect avoided, or incremental years of life saved. The value ofthe test may be expressed in terms of QALY, and compared toalternatives, creating a basis for measuring incremental value.

In some embodiments, the value of a diagnostic is the revenue to themanufacturer of a therapeutic treatment or other party generated byresults of a diagnostic that lead directly or indirectly to the use of aspecific therapeutic compound and/or treatment, device, regimen, oradditional diagnostic. The manufacturer of a therapeutic treatment orother party receiving this value, transfers some of the value to thediagnostic manufacture. For example, a drug manufacturer or drugmanufacturers make payments to the manufacturer of a diagnostic wheneveran individual begins a regimen of prescription drugs based on theresults of the diagnostic. Thus, if a test leads to therapy, the paymentscheme is triggered by the use of the therapy that the diagnostic hasrecommended and/or predicted will or likely will be successful, and thediagnostic manufacturer is able to profit from the value generated orrealized. In some embodiments, the value is a recurring value such as,for example, monthly sales of a prescription drug to an individual by adrug manufacturer.

For example, consider another statin example. If the statin diagnosticmanufacturer is able to create a useful action (in the form of thepatient staying on a particular statin for many years), the diagnosticmanufacturer would receive periodic payments from that statinmanufacturer, for as long as the patient stayed on that statin. For astatin manufacturer with a therapy with a small available percentage ofthe market (as defined by low response rate among individuals), thissystem transforms their standalone product into an integratedpay-as-you-go diagnostic-therapeutic model that enables a much highermarket penetration than would be affordable if the statin manufacturertested all patients up front for just their test.

In some embodiments, the value generated by a diagnostic is a savings.For example, savings to an insurance company attributed to beginningtreatment of a disease during an early stage of the disease in anindividual insured by the insurance company and diagnosed with thedisease based on a result of a diagnostic. Additionally, a diagnosticcan indicate that a drug will be ineffective for a particular patientand, thus, prevent unnecessary expenditures on that drug for theparticular patient.

After an estimated value is calculated, the diagnostic pricing isdetermined for the diagnostic that generated or realized that value at130. The value can be divided or converted into a price or cost underany number of formulas and including various factors as discussed inmore detail below. In some embodiments, the price varies based on theresult of the diagnostic. For example, a diagnostic that results inearly treatment of a disease or medical disorder and prevents costlycomplications, for which an insurance company would otherwise makepayments, can be priced at a percentage of the savings to the insurancecompany.

In some embodiments, the price of the diagnostic is paid by theindividual to whom the diagnostic is administered. For example, theprice can be charged to the patient or individual receiving thediagnostic. In other embodiments, another party receiving value from thediagnostic pays the price of the diagnostic. For example, an insurancecompany, a healthcare company, a drug manufacturer, and/or a drugdistributor can each receive value from the diagnostic and each mightpay a portion of the price of the diagnostic.

In some embodiments, the price is extended over a treatment period. Forexample, a drug manufacturer can make payments to the manufacturer of adiagnostic that produced results causing an individual or insurancecompany to purchase the drug from the drug manufacturer, each time theindividual or insurance company purchases the drug.

In some embodiments, payments are made over the same time period thatgenerally corresponds to the time frame during which value is generated.For example, payments can be made during the course of a therapeutictreatment resulting in payments to the manufacturer of the therapeutictreatment, or during a period of increased health attributable todetection of a medical disorder in an individual by the diagnostic andsubsequent therapeutic treatment. The time frame may be set by theparties involved based on clinical and other experience, as well asother relevant or related factors.

In some embodiments, a predetermined fixed price or payment of thediagnostic is initiated by a result of the diagnostic and remitted instages that approximate the time the diagnostic is expected to provideeconomic benefit or value. The calculation could be as simple as thediagnostic price divided by the number of years that the diagnostic willprovide benefit. For example, a $3,000 diagnostic expected to generate10 years of sales of a companion drug, might be charged to the drugcompany in increments of $300 per year for 10 years. This simplisticformula could also be modified to take into account, for example,probability assessments, net present value assumptions, as well as othermodifiers that would create a non-linear payment schedule. In someembodiments, the stages or phases of such a schedule are predetermined.

In some embodiments, the price and/or payment schedule of a diagnosticis based on a payment schedule and/or recurring fee or cost of atherapeutic treatment. For example, the price of a diagnostic can be arecurring fee based on a monthly charge for a therapeutic treatment suchas a prescription drug dose, a physical therapy regimen, and/or anexercise or preventative care regimen. In some embodiments, price isbased on past use of a diagnostic and actual use of a drug thatrequires, for example, as per an applicable FDA regulation, use of adiagnostic before the drug can be prescribed by a physician.

In some embodiments, the price is modulated (or adjusted) to dynamicallyreimburse and/or pay diagnostics manufacturers for the resultantdownstream profitability of a therapeutic treatment that is enabled bythe diagnostic. For example, a prescription drug manufacturer'sprofitability increases over time as production, distribution, and/orother costs associated with a prescription drug decrease. As theprescription drug manufacturer's profitability increases, the recurringprice or cost of the diagnostic increases such that the diagnosticmanufacturer is dynamically reimbursed for the profitability or valueenabled by the diagnostic. In some embodiments, the recurring price orcost of the diagnostic decreases in response to a decrease in theprescription drug manufacturer's profitability decreases. For example,the prescription drug manufacturer's profitability can decrease afterentry into the market of generic variants of a drug. In other words, thevalue enabled by the diagnostic can be dynamically transferred or sharedbetween a diagnostic manufacturer and a manufacturer of a therapeutictreatment. Such post hoc pricing for the diagnostic enables diagnosticmanufacturers and therapeutic treatment manufacturers to maximize thecombined amount of profit between them by forgoing value distributionuntil such value is can be more precisely calculated.

Similarly, in some embodiments, the price is modulated to dynamicallyreimburse and/or pay diagnostics manufacturers for the resultantdownstream profitability of a therapeutic treatment that is solelyand/or specifically enabled by the diagnostic. In some embodiments, forexample, the diagnostic manufacturer is paid based on the actualprescriptions written, average profitability of new patients, or anyother method agreed upon.

In some embodiments, the diagnostic price is set or determined based onan algorithm that divides economic value of a diagnostic between partiesassociated with the results of the diagnostic including, for example,parties responsible for selecting a therapy, selecting optimal therapyand/or selecting a change in behavior, lifestyle, or diet. For example,one price can be associated with a physician using the results of adiagnostic to make a medical or health-related recommendation, andanother price can be associated with the use of a drug based on theresults of the diagnostic.

Process 100 can be rearranged and/or include more or fewer steps. Forexample, a value of the diagnostic can be predetermined before thediagnostic is administered. In one embodiment, process 100 can includedetermining whether a result of a diagnostic is one of two or morepredetermined results.

Furthermore, in some embodiments, an initial amount is paid at the timethe diagnostic is administered, then additional periodic, for example,monthly, quarterly and/or annually, and/or an additional endingreconciling payments are made. Such reconciling payments can becalculated to consider actual payments made or accrued, improvedapproximations, actual economic value created and/or savings created.Such payments may be netted against the financial impact of otheradministrations of diagnostics between the same parties and/or otherparties to simplify accounting of this pricing embodiment. For example,an insurance company can make a single monthly payment to a diagnosticmanufacturer that is based on initial estimates of cost savings and thenin a future period paying reconciling amounts based on net calculatedsavings generated by the administration of such diagnostics to thegroup, rather than effect payment for each individual diagnostic user.

Additionally, in some embodiments, the payments made, or accrued as aresult of the economic value of administration of diagnostic, arerefunded if the diagnostic is found to be inaccurate. In other words, ifa diagnostic predicts responsiveness to a treatment, or prediction of adisease state, or non-disease state, and such prediction is proven orshown over time to be invalid or incorrect, for example, due to thenature of human disease or treatment effects, then the diagnostic owner,will rebate the price of the diagnostic, or price paid over time.

In some embodiments, an additional refund payment, above and beyond theoriginal, estimated and/or over-time price of the diagnostic is made ifthe diagnostic is incorrect or inaccurate. In some such embodiments, thediagnostic manufacturer creates the equivalent of an insurance fund poolto pay patients and/or payors of the diagnostic of those patients (e.g.,insurance companies and/or healthcare organizations) for whom thediagnostic has generated false positives, false negatives, and/or otherincorrect or inaccurate diagnosis or combination of diagnoses.

Consider, for example, a particular diagnostic that is reputed tocorrectly predict occurrence and/or recurrence of a certain type of adisease 98% of the time. Those 2% of patients who in later years areafflicted with the disease state contrary to the prediction or diagnosisof the diagnostic, will be entitled to a refund of the initial pricepaid for the diagnostic. In some embodiments, such patients will receiveadditional payments of a material or non-material amount to, forexample, help pay for additional treatment due to an inaccuratelypredicted disease state. Such payments may be contractually limited tothe form of a therapeutic treatment that is linked to the diagnostic,rather than monetary payment.

Such embodiments enable a payment system to function as a warrantee to,for example, create or increase a sense of emotional and financialsecurity to those taking the test. Such a sense of emotional and/orfinancial security can increase the appeal and use of diagnostics. Thusincreasing revenue for diagnostic manufacturers, manufacturers oftherapeutic treatments, and/or other parties as greater numbers ofindividuals are matched with appropriate therapeutic treatments based onresults of diagnostics.

FIG. 2 is a flow chart of 200 process for determining a price of adiagnostic, according to another embodiment. Data regarding the resultsof a diagnostic are received at 210. The data can be any representationor indication of an outcome of a diagnostic and/or can include theresults of a diagnostic. The data can be, for example, a reportincluding the results of the diagnostic, data from the diagnostic thathave not been previously analyzed to determine a result of thediagnostic, and/or digital data as described above.

As illustrated at 220 of process 200, in some embodiments, it isdetermined whether the result of a diagnostic is one of two or moreresults. For example, it can be determined whether the result of thediagnostic indicates a first biological state or a second biologicalstate such as, for example, the presence of a disease (a firstbiological state) or the absence of a disease (second biological state).

In some embodiments, the result of a diagnostic indicates the likelihoodof one or more biological conditions or outcomes of a therapeutictreatment. For example, a diagnostic can indicated that an individualwill likely respond positively to a therapeutic treatment such as, forexample, a treatment period with a particular drug or a gene therapytreatment. In some embodiments, one result of a diagnostic can indicatethat an individual is likely to develop a disease or disorder, andanother result can indicate that the individual is not likely to developthe disease or disorder. In other embodiments, a diagnostic can indicatethat an individual will or likely will have an adverse reaction to atherapeutic treatment, and another result can indicate that theindividual is no likely to have an adverse reaction to the therapeutictreatment.

After the result of the diagnostic is determined, a price or cost to becharged to the payor of the diagnostic is set or determined. Asillustrated at 260 and 240 of process 200, the price varies based on theresult of the diagnostic and can be determined by various methods, asdiscussed below. If the result is a first result, a first price is setfor the diagnostic, at 260. If the result is a second result, a secondprice different from the first price is set for the diagnostic, at 240.In some embodiments, a price for a result causing, suggesting, resultingin, or prompting a change in a treatment, a change in lifestyle and/orinitiation of a treatment is greater than a result not causing,suggesting, resulting in, or prompting such a change.

In one embodiment, the price of the diagnostic dynamically changes toaccount for change in economic value with the expected value of theinformation that may be received, as well as the value of theinformation that is actually received. For example, if the result is thefirst result, the price is a nominal administration fee; but if theresult is the second result, the price is set as follows:

Price Multiplier A×Price Multiplier B×Base Price of Diagnostic=FinalPrice of Test,

-   -   where    -   Price Multiplier A is related to expected clinical utility of        information that relates to the person being tested, including        age, disease state, or other independent variable,    -   Price Multiplier B is related to the quality of information,        where a zero may be recorded for a negative (e.g., non-diseased        state) result, to a higher factor for the result of the        diagnostic that shows a positive (e.g., diseased state) result        and good sensitivity and selectivity data, to a 1.00 for        positive data that is virtually unchallengeably useful.

In another embodiment, the price paid or charged for the diagnosticranges from zero to a full maximum of a list price of the diagnostic.Such a price could be determined using a multiplicative factor couldranging from zero for those testing negative, to, for example, 0.01,0.02, 0.05, 0.10, 0.15, 0.20, 0.35, 0.40, 0.50, up to 1.00, and possiblyexceeding 1.00 depending on the validity, specificity, sensitivity,predictive value, expected clinical utility, outcome or time frame inwhich the results will show clinical utility, economic benefits and/orother benefits for those testing positive.

For example, a $5,000 base price for a particular result is set for adiagnostic predictive screening test for a cancer typically seen only inwomen older than 65 years old. If the person tested is an 20-year oldwoman, the test may be priced using a price factor of 0.20 resulting inan effective price of $1,000 (0.2×$5,000), as might be appropriate forthe tested person for whom the diagnostic is expected to have lowclinical utility. Such expected utility would be calculated as higher,based on an increased multiplicative factor, for a woman who is aged 40,and still higher for a women aged 60, with corresponding higher pricesfor the diagnostic due to the higher increased expected utility.

In one embodiment, the payor (e.g., the patient of another entity forwhich the diagnostic can generate value) is only charged a nominalpaperwork fee, for example $20 for each test administered. When a testreveals a positive result (i.e., one with economic or other value), aprice of, for example, $3,000 is charged for the diagnostic. If the testreveals a negative result (i.e., one with little or no value), noadditional price is charged. In some embodiments, different parties payfor the diagnostic based on the outcome of the diagnostic. For example,the individual receiving the diagnostic pays for the diagnostic if theresult is negative, and an insurance company pays for the diagnostic ifthe result is positive.

In some embodiments, the price is charged to and/or paid by a partyother than an individual receiving a diagnostic. For example, a drugcompany administering the diagnostic to screen for individuals to whomits drug will be beneficial may pay the price to a diagnosticmanufacturer or distributor. In some embodiments, the price of thediagnostic may be charged to the insurance company insuring anindividual receiving the diagnostic.

In some embodiments, process 200 can include additional and/orrearranged steps. For example, process 200 can include one or more stepsfor determining a value (e.g., economic or societal) of the first resultand/or the second result, and the price can be based on the value.

FIG. 3 is a flow chart of process 300 for determining a price of adiagnostic, according to another embodiment. An initial price for adiagnostic is charged at 310. The initial price can be, for example, anominal, minimal or administrative fee or charge. For example, adiagnostic manufacturer can provide a diagnostic to an insurance companyfor the price of shipping the diagnostic to the insurance company. Insome embodiments, the diagnostic can be provided directly to anindividual who will use the diagnostic. In some such embodiments, thediagnostic is intended for use without the supervision of a physician.In other embodiments, the initial price can be a more substantialamount, but less than an expected, estimated and/or potential value ofthe diagnostic or results of the diagnostic.

The diagnostic is administered at 320. The diagnostic can beadministered by, for example, a physician to a patient. In someembodiments, administration of the diagnostic can be effected by aninsurance company. For example, the insurance company can provideclinics for administering the diagnostic. In some embodiments, aninsurance company can indirectly effect administration of thediagnostic. For example, the insurance company can send a diagnosticintended for use without supervision of a physician to an individual.The individual uses the diagnostic and can send the results and/orsample from the diagnostic to the insurance company or some other entityfor analysis. In some embodiments, a diagnostic manufacturer candirectly or indirectly effect administration of a diagnostic.

Data regarding the results of a diagnostic are received at 330. The datacan be any representation or indication of the results of a diagnosticand/or including the results of a diagnostic. The data can be, forexample, a report including the results of the diagnostic, data from thediagnostic that have not been previously analyzed to determine a resultof the diagnostic, and/or digital data as described above.

As illustrated at 340 and 350 of process 300, the price of thediagnostic varies based on the result of the diagnostic. If the resultis a first result, at 340 a first price other than the initial price ischarged for the diagnostic. If the result is a second result, at 350 asecond price other than the initial price and different from the firstprice is charged for the diagnostic. The first result can be, forexample, a result indicating a diseased state and/or that a particulartherapeutic treatment will be effective. The second result can be, forexample, a result indicating a non-diseased state and/or that aparticular drug will have adverse reactions or be ineffective.

Consider a patient considering whether to pay for a $3,000 test thatindicates whether they have a gene variant that enables them to forgo atherapy (such as Interferon for Hepatitis C) that often has debilitatingadverse affects. Assume that the gene variant only exists in 10% of thepopulation. Most, if not all patients would find the test useful, sinceit gives them a chance for a better quality of life. For purposes ofthis example, assume the value of the incremental quality of life isworth $120,000 per person who does not have to take the therapy.Although the expected value is positive, the chances are so small (1 outof 10) that many will not take the test, just as many rational peoplehave typical psychological biases that prevent them from betting $3,000to win $120,000 even if the expected value of the bet were in theirfavor. In the method proposed, the patient has a novel advantage. He orshe need not take an expected value “bet”. Instead the patient paysif—and only if—the test results benefit him or her. In the proposedmethod, all patients could take the diagnostic by paying a smallfee—perhaps $20.00 to process the sample and deliver results. Thetesting center would run the patient's test alongside with hundreds,perhaps thousands of identical tests from other patients making for verystrong efficiencies. At the conclusion, a second price—say $30,000—ischarged if the test delivers useful, valuable results that enable thepatient to capture the benefits (worth $120,000) from not taking thedebilitating therapy. This method transforms a purchase withprobabilistic uncertainty of value into a known and valuable propositionfor the customer. The system by which this is effected involves initialtracking and processing of patient results to deliver a billing receipt.

In some embodiments, the first price is greater than the second pricebecause the first result will or will likely generate economic value.For example, an indication that a drug will be effective may generatedrug sales for a drug manufacturer. In some embodiments, the secondprice is higher than the first price because the second result preventsexpenditures. For example, an indication that a drug will be ineffective(e.g., because a patient's body will not positively respond to the drug,is not affected by a disease or condition, or will not be affected by adisease or condition) may prevent unnecessary expenditures by aninsurance company or an individual.

In some embodiments, the first price is between two and ten timesgreater than the second price. In some embodiments, the first price isbetween ten and one hundred times greater than the second price. In someembodiments, the first price is more than one hundred times greater thanthe second price.

In some embodiments, the price (e.g., an initial price, a first priceand/or a second price) of the diagnostic is charged to an individualpatient by the diagnostic manufacturer. In another embodiment, the pricecharged to a manufacturer of a related therapeutic treatment. In anotherembodiment, the price is charged to a health maintenance organization(“HMO”), preferred/participating provider organization (“PPO”), orsimilar insurance or managed care provider with economic and contractualrecourse for the health costs of the end-user patient.

In some embodiments, various prices associated with a diagnostic arepaid by different parties. For example, an initial price for adiagnostic test can be paid by an individual receiving the diagnosticand a first price or a second price based on the result of thediagnostic is paid by an insurance company. In some embodiments, theinitial price for a diagnostic can be paid by a drug manufacturer and afirst price or a second price based on the result of the diagnostic ispaid by an insurance company.

In some embodiments, the charge in addition to the initial price onlyoccurs when the diagnostic provides useful results, which do notnecessarily have to be quantitative or qualitative. Usefulness may alsobe assessed in other methods. Takemura, et al, “Yield and Cost ofIndividual Common Diagnostic Tests in New Primary Care Outpatients inJapan”, Clinical Chemistry, 2002; 48: 42-54, which is incorporatedherein by reference in its entirety, is an example of a rating systemfor assessing usefulness of a diagnostic and describes the ratingssystem of the Japan Society of Clinical Pathology. Takemura describes auseful result of a diagnostic as a finding that contributed to a changein the physician's diagnosis or decision-making relating to a tentativeinitial diagnosis (“TID”) based on history and physical examinationalone. In addition, a useful result occurs when results of a diagnosticcontribute to evaluation of the nature and/or severity of a disease, andare followed by a change in a physician's decision making. For example,a useful result might result in a change in the treatment and/ormanagement of the patient, additional ordering of organ- ordisease-specific tests, reference to a specialist, or transfer of apatient to a specific clinic.

In some embodiments, the charge in addition to the initial price for thediagnostic only occurs when the outcome of the diagnostic directlyresults in prescription of a therapeutic treatment to the patienttested. For example, when the outcome of the diagnostic indicates adiseased state and/or that a particular therapeutic treatment will beeffective. In some embodiments, the selection of therapeutic treatmentresults directly from the information conveyed by the results of thediagnostic.

In some embodiments, the charge in addition to the initial price for thediagnostic only occurs when the outcome of the diagnostic directlyresults in prescription to the patient tested of a course of therapythat does not include a specific therapeutic treatment or combination oftherapeutic treatments. For example, when the outcome of the diagnosticindicates a non-diseased state, that a particular therapeutic treatmentwill not be effective, and/or that the patient will have adversereactions to a particular therapeutic treatment. Such outcomes can, forexample, prevent unnecessary and/or useless expenditure on therapeutictreatments that would be ineffective. In some embodiments, the selectionof the prescribed course of therapy is a result of the informationconveyed by the results of the diagnostic.

In some embodiments, process 300 can include additional steps and/or berearranged. For example, process 300 can include one or more steps fordetermining whether a therapeutic treatment suggested or recommendedbased on a result of a diagnostic is useful or beneficial. A therapeutictreatment is useful or beneficial when it effectively treats a medicalcondition. For example, in some embodiments, no price is charged until amedical condition has been successfully treated with a drug recommendedby a diagnostic. Thus, in some embodiments, the price will be chargedonly when the result, prediction and/or recommendation of a diagnosticis shown to be correct or accurate.

FIG. 4. is a flow chart of process 400 for distributing a diagnostic,according to an embodiment. Process 400 allows a third party to managethe distribution and cost collection of diagnostics. Process 400 can beimplemented and/or realized by, for example, a clearing house ordistributor of diagnostics according to the methods described herein. Adiagnostic is provided to a first party at 410. The diagnostic can beprovided to, for example, a hospital, a physician, an HMO, a PPO, orother entity for administering the diagnostic. In some embodiments, thediagnostic is provided directly to an individual for use.

The first party administers the diagnostic or effects administration ofthe diagnostic at 420. For example, an insurance company can effectadministration of a diagnostic intended and approved for use without theassistance of a physician, by providing the diagnostic to an individualwith instructions for use. In some embodiments, a physician administersthe diagnostic to a patient.

At 430, data associated with the results of a diagnostic are received.The data can be any representation or indication of the results of adiagnostic and/or including the results of a diagnostic. As describedabove, the data can be, for example, a report including the results ofthe diagnostic, or data from the diagnostic that has not been previouslyanalyzed to determine a result of the diagnostic. In some embodiments,the data are digital data such as, for example, a representation of amass spectrum or assay analysis of a diagnostic. In some embodiments,the data are a blood sample, a tissue sample and/or other biologicalsample, for example. In some embodiments, the data can be a report suchas, for example, an electronic or paper document including informationassociated with the diagnostic.

In some embodiments, the data are received from the first party. Inother embodiments, the data are received from the person administeringthe diagnostic. In other embodiments, the data are received from ananalyst providing some analysis of the diagnostic. For example, adiagnostic can include taking a blood sample and adding a chemical tothe blood sample to test for abnormalities in blood. The blood samplewith the added chemical can be analyzed by a laboratory before the dataare received.

After the data are received, a cost is collected from the first party at440. The cost collected can be based on a value of the diagnostic asdescribed herein. In some embodiments, the cost is an additional costthat supplements an initial fee charged before the diagnostic isprovided to the first party at 410, but not described in FIG. 4. In someembodiments, the cost is passed from the first party to the individualto whom the diagnostic was administered, or to an entity, such as aninsurance company, responsible for some or all of the medical expensesof the individual or the first party. The cost can then be collectedfrom the individual or other entity.

A portion of the cost is provided to a second party at 450 after thecost is collected. In some embodiments, the second party is a diagnosticmanufacturer. The portion of the cost can be based on a percentage ofeach diagnostic price, a fixed periodic charge for the diagnosticmanufacturer, and/or some other arrangement.

Process 400 can be rearranged and/or include more or fewer steps thanshown in FIG. 4. For example, process 400 can include a step forcalculating or determining a value of a diagnostic and/or a cost basedon the value.

In some embodiments, methods and apparatus related to diagnostic pricingdiscussed herein can be applied to previously sequenced patient DNA. Inother words, sequenced patent DNA information can be interrogated ortested by one or more diagnostics after the patient DNA information hasbeen sequenced and stored at a memory such as a database. The DNAinformation in the database can be analyzed to discover and/or identifymutations, single nucleotide polymorphisms (“SNPs”), and/or markers thatare related to a diagnostic or genetic test.

For example, FIG. 6 is a flow chart of process 600 for performing adiagnostic, according to an embodiment. Patient data such as DNA orother genetic material is collected, at 610, via blood, cheek or nasalswab, or other means, and that genetic material is sequenced and/oranalyzed, at 620. The results of the analysis and/or sequencing can thenbe stored, at 630, at a memory such as a database. For example, the rawsequenced genetic data can be stored at a portion of a database at atesting facility or company. In some embodiments, that portion of thedatabase is uniquely associated with the patient (e.g., is encryptedand/or identified by an identifier uniquely associated with thepatient).

At a later time, and in some embodiments independent of the geneticmaterial sequencing, a physician or other individual such as the patientcan order a diagnostic or genetic test using the stored results of thesequencing. Patient identification data are transmitted by, for example,the physician's office to the testing company with a request for a testor diagnostic. The request for the diagnostic or test is received, at640, and the patient identification data are matched to the sequencedDNA or genetic information (the “DNA profile”) in the database at thetesting company. After the patient identity is matched to the DNAprofile, the test can be performed, at 650. For example, a test workorder for the diagnostic or diagnostics can be queued for processing inan informatics system. An informatics system can include, for example,one or more computing devices such a computer servers configured toprocess DNA profiles at multiple software modules (e.g., softwareprocesses or applications) configured to implement one or morediagnostic tests to determine results of the diagnostic tests based onthe DNA profiles and algorithms, patterns, and/or processes related tothe diagnostic tests.

In some embodiments, the diagnostic or diagnostics are performedelectronically on the DNA profile, and results are calculated for thediagnostic or diagnostics. For example, the informatics system caninterrogate the DNA profile and/or other patient data for specificmarkers and/or sequences that are relevant to the diagnostics ordered.The informatics system can then compare the interrogated (or analyzed)portions of the DNA profile with patterns and/or algorithms that arepart of the diagnostics ordered. The raw stored/banked genetic data arethereby transformed into a useful test result by the comparison to thespecific markers and/or sequences that are known to have usefulpredictive properties. In other embodiments, the genetic data can betransformed into a useful test result using other methods and/orapparatus. In some embodiments, such patterns, algorithms, and/orrelated processes and apparatus are part of the intellectual property ofthe testing company or some other entity. The results of the diagnostic(e.g., likelihood of the presence or absence of a disease) can bedetermined, at 660, based on, for example, the existence ornon-existence of relevant markers and/or sequences.

The results can then be stored, for example, at the database, and/orconveyed to the physician and/or patient, at 670. For example, theresults of the test can be sent to a physician's office (e.g., acomputing device or terminal at the physician's office) via acommunications network. After the results are received, billing codesand/or patient identity information can be confirmed and payment can beprocessed, at 680. For example, payment can be processed as describedherein.

In some embodiments, process 600 can include more or fewer steps thanillustrated in FIG. 6, and/or steps can be rearranged. Similarly, somesteps of process 600 can be performed by different entities. Forexample, a clinician or a data collection facility can collect patientdata, analyze that patient data, and store that patient data. Thatpatient data can be sent to a diagnostic facility with a request for adiagnostic test, and the diagnostic facility can use the patient data itreceives from the collection facility to perform the requesteddiagnostic. The diagnostic facility can determine the results of thediagnostic test, send the results of the diagnostic test to thecollection facility, and effect billing for the diagnostic test.

In some embodiments, one or more diagnostics (or tests) can be bundledwith pre-determined pricing related to patient utility. Such a systemcan extract maximum value from specific panels or groups of low marginalcost tests such as genetic tests that are all—separately and/orcollectively—relevant to a medical condition or disease state.

Many tests with genetic components have limited clinical utility asstandalone tests. For example, results from a single test can provideuseful information and identify known risk factors, but such results maynot sufficiently support change of treatment decisions based on thesingle result or risk factors. Consider genetic variants that are knowncardiac risk factors. Hundreds of clinically appropriate variants exist.Moreover, additional variants are likely to be discovered. If the testpanel is not already created as a bundled package, it is often costprohibitive for the physician to test for every variant that might showbearing on a patient's cardiac risk. A particular test, however, may bemuch more useful when used in conjunction with other related tests.Nevertheless, there is generally resistance to ordering a battery of allpossible relevant tests due to costs. The combined value of a group ofmedically relevant tests run or performed at the same time, however, canbe significantly greater than the sum of those same individual tests runas stand-alones. In other words, the value of the results of thecombination of the tests can be of great value even when the value ofeach of the test individually is small.

In some embodiments, a group of tests can be combined (e.g., by aphysician, a marketing company, or one or more drug manufacturers) intoa single panel that is priced lower than the price of all the tests asstandalones. In some embodiments, a panel can be customized to aparticular patient. In other words, a panel can be patient-specific orcan be a generic panel applicable to many different patients. Thedesired outcome is for the panel (and, thus, the diagnostics of whichthe panel consists) to be used more frequently than any of the tests asa stand-alone test. For example, six tests owned by six separate partiesare combined in a panel that has a price of $1,000. Five of the testsare useful, but are rarely ordered as standalone, and the sixth test ismore useful as a standalone, though its clinical utility (e.g., accuracyand/or precision at predicting or detecting a diseased state) isvalidated by the other five tests. When the test is ordered, the $1,000is distributed to each of the first five test owners at $100 per test,and $500 is distributed to the owner of the sixth test. Thus, the rateof return to the owners of each of the tests (or to the owners of theintellectual property involved in each of the tests) as standalones canbe approximated in the distribution of the cost for the panel of tests.In other words, the owner of the sixth tests receives a larger portionof the cost of the panel because the sixth test is more frequently usedas a standalone than the other five tests.

Other distributions of the cost of the panel of tests to the owners ofeach individual test (or the owners of the intellectual property used ineach of the individual tests) can also be used. For example, the ownersof each individual test in the panel can receive an equal share of thecost (or profit) from the panel of tests. In some embodiments, the costof the panel can be distributed based on a production cost of each ofthe individual tests. In some embodiments, the owner of the test in thepanel that can validate the clinical utility of one or more other testsin the panel receives a majority share of the cost. Various otherdistributions of the cost of the panel of tests (or of economic benefitderived from a panel of tests by, for example, a drug manufacturer) canalso be used.

In some embodiments, a multi-part pricing structure is used for groupsof low-marginal cost tests (e.g. genetic tests) to maximize the validityof clinical decisions and therefore maximize the possible value to theentire group of test providers. For example, a two-part pricingstructure or tariff can be utilized. A first price (e.g., zero or someother fixed price) is paid to have the panel run and analyzed. Thesecond fixed price is paid contingent on the physician successful makingan informed clinical decision based on the combined information from alltest results. This second price is distributed to the owners of theindividual tests or the intellectual property of the individual tests ina predetermined percentage formula. For example, a panel can include sixtest owned by six separate parties, and the panel that has a first priceof $100 and a second price of $1,000. Five of the tests are helpfulthough rarely ordered as standalone, and the sixth test is more usefulas a standalone and its clinical utility is validated by the other fivetests. The first price can be paid immediately upon the test beingordered to cover the costs of the tests and administration thereof. Thesecond price can be paid if, and in some embodiments only if, theclinician administering the tests or analyzing the results of the testsfinds the results useful. If the results are found to be useful, the$1,000 can be distributed to each of the first five test owners at $100per test, and $500 can be paid to the owner of the sixth test.

As discussed above, other distributions or divisions of the cost of apanel of tests (or of economic benefit derived from a panel of tests by,for example, a drug manufacturer) can also be used to compensate theowners of the individual tests in the panel. For example, the owner ofeach test in the panel can receive an equal share of a cost of oreconomic benefit derived from the panel if the results of the panel areuseful to a clinician, physician, and/or patient. In some embodiments,the owners of the tests in the panel that validate the clinical utilityof other tests in the panel can be compensated at a greater percentagethan the owners of the tests in the panel that are validated by othertests. In other embodiments, various other distributions or divisions ofthe cost of a panel of tests (or of economic benefit derived from apanel of tests by, for example, a drug manufacturer) can also be used.

Additionally, in some embodiments three- or four-part (or more) pricingstructures can be used. For example, one price can be paid upfront tocover the costs of a panel of tests, a second price can be paid orcharged if the panel of tests suggests a first result, and a third pricecan be paid or charged if the panel of test suggests a second result. Insome embodiments, one distribution is used to compensate the owners ofthe tests if the panel of tests suggests the first result and the secondprice is charged, and another distribution is used to compensate theowners of the tests if the panel of tests suggests the second result andthe third price is charged. In some embodiments, a portion of the firstcost can be distributed to one or more of the owners of the tests. Forexample, a portion of the first cost can be distributed to the owner ofthe test in the panel that is most frequently used as a standalone, andno portion of the first cost is distributed to the owners of the othertests in the panel. In other embodiments, the owner of each of the testsin the panel can receive an equal, upfront share of the first price.Various other multi-part pricing structures related to the cost of thepanel of tests (or of economic benefit derived from a panel of tests by,for example, a drug manufacturer) can also be used.

FIG. 7 is a flow chart of process 700 for realizing a multi-part pricingstructure, according to an embodiment. A first price is charged for adiagnostic panel, at 710, and the diagnostic panel is administered, at720. The results of the diagnostic panel are then analyzed, at 730. Ifthe results are determined to be not useful, at 740, not additional costor price is charged or collected, at 741. In other words, if the resultsof the diagnostic panel are not useful, the owners of the diagnostics inthe diagnostic panel do not receive additional revenue from thediagnostic panel.

If the results of the diagnostic panel are determined to be useful, at740, at physician or clinician can use the results of the diagnosticpanel to recommend a treatment plan (e.g., a therapeutic drug regime),at 750. If results of the diagnostic panel are useful, but the physiciandoes not recommend a treatment plan, at 750, an additional cost for thediagnostic panel is charged or collected, and is divided equally amongthe owners of the diagnostics in the diagnostic panel, at 751. If thephysician does recommend a treatment plan, at 750, the patient caneither accept or reject the treatment plan, at 760.

If the patient rejects the treatment plan, at 760, an additional costfor the diagnostic panel is charged or collected, and is divided using afirst distribution among the owners of the diagnostics in the diagnosticpanel, at 761. For example, the additional cost can be divided such thatthe owner of the diagnostic that is most frequently used as a standalonereceives a disproportionate share of the additional cost and the ownersof the remaining diagnostics from the diagnostic panel share equally theremainder of the additional cost. In other embodiments, otherdistributions can be used.

If the patient accepts the treatment plan, at 760, an additional costfor the diagnostic panel is charged or collected, and is divided using asecond distribution among the owners of the diagnostics in thediagnostic panel, at 762. For example, the additional cost can bedivided such that the owner of a diagnostic that validates the clinicalutility of one or more of the other diagnostics in the diagnostic panelreceives a disproportionate share of the additional cost and the ownersof the remaining diagnostics from the diagnostic panel share equally theremainder of additional the cost. In other embodiments, otherdistributions can be used.

In some embodiments, process 700 can include more or fewer steps thanillustrated in FIG. 7, and/or steps can be rearranged. For example,process 700 can include additional steps for determining the period oftime over which the patient remains on the treatment plan and can alterthe distribution of additional costs (e.g., therapeutic drug sales) thatare shared among the owners of the diagnostics in the diagnostic panelover time. In other words, the percentage of an incremental valuerealized or effected by the diagnostic panel that each owner of thediagnostics in the diagnostic panel can vary over time (e.g., monthly oryearly) while the patient remains on the treatment plan.

In some embodiments, tests such as pharmacogenomic diagnostic tests canbe used as a marketing tool for, for example, referral-fee basedadvertising and marketing activities for drug manufacturers. Drugmanufacturers, therapeutic treatment facilities, or marketing entitieson behalf of drug manufacturers or therapeutic treatment facilities, canprovide low-cost or free independent tests to patients as promotionaldecision support materials. In other words, the tests are given away, orprovided at low cost by the marketing entity at no cost to physiciansand patients to indicate which patients may be best served by a specifictherapeutic or therapeutic combination. Such marketing materials aresimilar to any other free tools, such as the Nexcura™ tool provided bythe America Heart Association, that seek to aid physicians andclinicians in making correct diagnoses.

The physician or clinician administering or analyzing the results of thetest is free to use or discard the information in the test results, justas he or she may discard the results of any other test in making thediagnose. The marketing company can be paid a per-referral fee by thesponsoring company (e.g., drug manufacturer or therapeutic treatmentfacility) for each patient prescribed the drug or therapy or that isidentified as a good candidate for the therapy by a physician orclinician. In some embodiments, the marketing company is paid theper-referral fee if the patient agrees to and begins the therapy. Thephysician is paid a reimbursement for the blood draw in an amountcommensurate the normal reimbursement for the test, if it were a regularpaid test. Thus, the doctor's independent judgment regarding patientcare is uncompromised because the marketing company does not act onbehalf of a physician in selecting the particular therapy, and thephysician is not compensated for prescribing a particular therapy orcourse of treatment. Moreover, neither the physician nor the patient isobligated to select a particular course of treatment if the test (or apanel of tests) provides a predetermined result. In other words, thepurchase of a particular therapy is not tied to the receiving of thefree or low cost test. Furthermore, the physician is not compensated forenrolling his patients into the promotional testing program. Rather, thephysician and patient are provided with low-cost tools to select afavorable course of treatment, and the financial beneficiary of thatcourse of treatment (e.g., drug company or therapeutic treatmentfacility) receives increased distribution of information about itsservices and/or products to patients who will most benefit from thoseservices and/or products.

For example, a marketing company can provide full reimbursement fordiagnostic tests for statin therapeutic response. A physician can usethe information from a diagnostic test or a panel of diagnostic tests tohelp decide on a course of treatment that may or may not include aparticular statin therapy. Such a marketing initiative requires acomputer system for tracking patient outcomes for those patients whoreceive the free test to calculate effectiveness yield of the marketingcampaign and determine reimbursement over time. The arms-lengthrelationships between the marketing company providing (e.g., givingaway) the tests, the physician, and therapeutic company preventspotential conflicts of interest.

In some embodiments, a third party tracks and/or manages calculatedvalues of diagnostics, payments to and from various parties fordiagnostics, and/or contractual conditions agreed upon at the time ofthe diagnostic. For example, an individual might agree to purchase atherapeutic treatment for a predetermined amount of time if thediagnostic produces a particular result, in exchange for receiving thediagnostic at a reduced cost. In some embodiments, the third party cantrack, record, calculate, audit and/or adjust recurring paymentsresulting from the use of the diagnostic. For example, if a person wasprescribed a therapeutic drug as a result of a diagnostic and stayed ona therapeutic treatment for 10 years, the third party can collect from apayor a diagnostic fee each year until the patient stops taking thedrug.

In some embodiments, if the patient discontinues the therapeutictreatment, payments also cease. In other embodiments, payments for thediagnostic continue for a fixed period of time regardless of continueduse of a therapeutic treatment. In some embodiments, payments for thediagnostic can end before the therapeutic treatment ends. For example,if the patient stayed on a therapeutic treatment for 30 years, the thirdparty may collect payments for only 20 years.

In some embodiments, individual patients have their diagnostic andtherapeutic treatment usage tracked and recorded by the third party andfuture liabilities estimated by the third party, connected parities, orunassociated parties through predictive and actuarial analysis.

In one embodiment, the third party manages payments from insurancecompanies when individuals who have received the diagnostic changeinsurance companies or insurance plans. For example, the third party canstop collecting from the insurance company of a patient who switchesproviders, and begin charging the new insurance provider, if any, forthe continuing diagnostic costs of the patient. Additionally, the thirdparty can collect from an individual any costs not covered by theindividual's insurance coverage.

In one embodiment, a computing device including, for example, aprocessor and a memory is used to calculate, manage and/or tracktransactions, and net them to each party (e.g., diagnostic manufacturer,insurance company, drug manufacture) based on each party's net inflowand/or outflow of diagnostic payments.

FIG. 5 is a system block diagram of system 500 for pricing a diagnostic,according to an embodiment. System 500 includes pricing server 510,diagnostic manufacturer terminal 560 and diagnostic administratorterminal 520 operatively coupled to communications network 530.Communications network can be, for example, a computer network or atelephony network. In some embodiments, communications network can be acombination of networks coupled one to another by, for example, networkbridges, routers, switches and/or gateways.

Pricing server 510 can be associated with any entity managing, trackingand/or administering diagnostics pricing. For example, a clearing housefor managing diagnostics pricing between one or more diagnosticmanufacturers and one or more diagnostics administrators such asinsurance companies, drug manufacturers and hospitals can be associatedwith a pricing server. In some embodiments, pricing server 510 can bedirectly associated with a diagnostics manufacturer.

Diagnostic manufacturer terminal 560 can be associated with amanufacturer of diagnostics and/or a diagnostics distributor. Diagnosticadministrator terminal 520 can be associated with any entity responsiblefor and/or directly or indirectly effecting administration ofdiagnostics. For example, a diagnostics administrator such as aninsurance company, a drug manufacturer or a hospital.

Pricing server 510 is coupled to communications network 530 viaconnection 540; diagnostic manufacturer terminal 560 is coupled tocommunications network 530 via connection 590; and diagnosticadministrator terminal 520 is coupled to communications network 530 viaconnection 550. Connections 540, 550 and 590 are any connectionssuitable for coupling pricing server 510, diagnostic manufacturerterminal 560 and diagnostic administrator terminal 520 to communicationsnetwork 530.

As illustrated in FIG. 5, pricing server 510 includes interface 512,processor 515 and memory 517. Processor 515 is operatively coupled tointerface 512 and memory 517. Diagnostic manufacturer terminal 560 anddiagnostic administrator terminal 520 include similar elements toprocessor 515, interface 512 and memory 517 of pricing server 510.

Processor 515 can be any of a variety of processors. Such processors canbe implemented, for example, as hardware modules such as embeddedmicroprocessors, microprocessors as part of a computer system,Application-Specific Integrated Circuits (“ASICs”), and ProgrammableLogic Devices (“PLDs”). Some such processors can have multipleinstruction executing units or cores. Such processors can also beimplemented as one or more software modules in programming languages asJava™, C++, C, assembly, a hardware description language, or any othersuitable programming language. A processor according to some embodimentsincludes media and computer code (also can be referred to as code)specially designed and constructed for the specific purpose or purposes.

Interface 512 can be any interface configurable to be operativelycoupled to communication network 530 via connection 540. For example, anetwork interface can be a wireless interface such as, for example, aworldwide interoperability for microwave access (“WiMAX”) interface, ahigh-speed packet access (“HSPA”) interface, and/or a WLAN interface. Anetwork interface can also be, for example, an Ethernet interface, abroadband interface, a fiber-optic interface, and/or a telephonyinterface.

Memory 517 can be a read-only memory (“ROM”); a random-access memory(“RAM”) such as, for example, a magnetic disk drive, and/or solid-stateRAM such as static RAM (“SRAM”) or dynamic RAM (“DRAM”); and/or FLASHmemory or a solid-data disk (“SSD”). In some embodiments, a memory canbe a combination of memories. For example, a memory can include a DRAMcache coupled to a magnetic disk drive and an SSD.

In addition to memory 517, some embodiments include anotherprocessor-readable medium (not shown in FIG. 5) having instructions orcomputer code thereon for performing various processor-implementedoperations. Examples of processor-readable media include, but are notlimited to: magnetic storage media such as hard disks, floppy disks, andmagnetic tape; optical storage media such as Compact Disc/Digital VideoDiscs (“CD/DVDs”), Compact Disc-Read Only Memories (“CD-ROMs”), andholographic devices; magneto-optical storage media such as flopticaldisks; solid-state memory such as SSDs and FLASH memory; and ROM and RAMdevices. Examples of computer code include, but are not limited to,micro-code or micro-instructions, machine instructions (such as producedby a compiler), and files containing higher-level instructions that areexecuted by a computer using an interpreter. For example, an embodimentmay be implemented using Java™, C++, or other object-orientedprogramming language and development tools. Additional examples ofcomputer code include, but are not limited to, control signals,encrypted code, and compressed code.

Pricing server 510 can send and receive data associated with diagnosticsfrom diagnostic administrator terminal 520, diagnostic manufacturer 560,and/or other terminals not shown in FIG. 5 via communications network530. For example, pricing server 510 can send and receive dataassociated with the results of a diagnostic, diagnostic pricing dataand/or financial data.

Additionally, pricing server 510 can determine and/or calculate, forexample, the value of a diagnostic, a price of a diagnostic and/or otherinformation relating to a diagnostic according to embodiments describedherein. For example, pricing server 510 can be operated by a clearinghouse for managing payments and/or for distribution of diagnostics.

In some embodiments, system 500 can include more or fewer terminalsand/or servers. For example, multiple diagnostic manufacturer terminalsand/or diagnostic administrator terminals can be operatively coupled toa single pricing server via a communications network. Additionally, apricing server can operate independent of diagnostic manufacturerterminals and/or diagnostic administrator terminals and a communicationsnetwork. For example, a diagnostic manufacturer can use a pricing serverinternally to automatically determine values and prices associated withone or more diagnostics.

In one embodiment, a marketplace is created where future diagnostichealthcare liabilities are combined and securitized into groups ofliabilities, or “tranches.” For example, as a result of a pricingembodiment whereby a third party can begin charging a new insuranceprovider for future diagnostic value generated for a past diagnostic ifa patient switches insurance providers, the insurance company may wishto make certain all future costs associated with such liabilities. Suchinsurance companies could bundle their liabilities and “sell” suchliabilities to another party, thereby locking in gains from theirdiagnostic use and purchase strategy and eliminating future paymentexposure. In another embodiment, such liabilities tranches could also beexpanded to comprise the future medical liabilities of any individuals,or groups of individuals, not limited to just diagnostic liabilities.For example, insurance plans may one day require that contingentliabilities for pre-existing conditions to be paid for by a priorinsurer. In such a case, these liabilities on future medical costexposure could also be bundled and securitized to enable the transfer ofrisk for these liabilities.

In one embodiment, a method of pricing a diagnostic test administered toa test subject includes receiving data associated with the diagnostictest and including an indication of one of a first result of thediagnostic test and a second result of the diagnostic test, and settinga price of the diagnostic test based on the indication. In someembodiments, setting a price of the diagnostic tests includes settingthe price based at least in part on a recurring cost of a therapeutictreatment associated with the indication. In some embodiments, themethod also includes charging a recurring payment for the diagnostictest based on the price of the diagnostic test. In some embodiments, themethod also includes determining a value associated with the indication.

In some embodiments, the first result indicates the presence of adisease and the second result indicates the absence of the disease. Insome embodiments, the first result indicates that a therapeutictreatment is desirable and the second result indicates that thetherapeutic treatment is not desirable. In some embodiments, the firstresult indicates that a therapeutic treatment is desirable and thesecond result indicates that the therapeutic treatment is not desirable.

In some embodiments, the price is greater if the indication is of thefirst result that the price if the indication is of the second result.In one embodiment, the price is at least one hundred times greater ifthe indication is of the first result than the price if the indicationis of the second result. In some embodiments, the price is zero if theindication is of the second result. In some embodiments, the price isvariable over time and based on the outcome of a therapeutic treatment.

In one embodiments, a method of pricing a diagnostic test includesreceiving data associated with the diagnostic test and including anindication of one of a first result of the diagnostic test and a secondresult of the diagnostic test, charging a first price for the diagnostictest if the indication is of the first result, and charging a secondprice greater than the first price for the diagnostic test if theindication is of the second result. In some embodiments, the first priceand/or the second price are predetermined (i.e., are determined beforethe data are received). In some embodiments, a portion of one of thefirst price and the second price is refunded if the indication isincorrect, inaccurate or erroneous.

In some embodiments, the first result occurs at least twice as often asthe second result in a general population. For example, a resultindicating that an individual has a rare disease occurs no more thanonce for every twenty individuals screened for the disease in a country.

In some embodiments, the first price is charged to a first party if theindication is of the first result, and the second price is charged to asecond party if the indication is of the second result. The second partyis different from the first party.

In some embodiments, the second price is a recurring payment. Forexample, a charge or payment made monthly. In some embodiments, thesecond price is based on a cost of a therapeutic treatment. In someembodiments, the therapeutic treatment is associated with the secondresult. For example, the second result can indicate that the therapeutictreatment will likely be effective in a particular patient.

In one embodiment, a method of determining a price for a diagnostic testincludes, receiving data associated with the diagnostic test andincluding an indication of one of a first result of the diagnostic testand a second result of the diagnostic test, calculating a value of thediagnostic test based on the indication, and determining the price forthe diagnostic test based on the value. In some embodiments, theindication is of the first result, the first result indicates adesirability of a therapeutic treatment having a treatment period, andthe price is based on the value of the diagnostic test over thetreatment period.

In some embodiments, the first result indicates a disease state and thesecond result indicates a non-disease state. In some embodiments, thefirst result indicates a predicted disease state and the second resultindicates a predicted non-disease state. In some embodiments, the firstresult indicates that a therapeutic treatment is desirable and thesecond result indicates that the therapeutic treatment is not desirable.

In one embodiment, a method of pricing a diagnostic test includescharging a first price for the diagnostic test before the diagnostictest is administered, receiving data associated with the diagnostic testand including an indication of one of a first result of the diagnostictest and a second result of the diagnostic test, charging a second pricefor the diagnostic test if the indication is of the first result and athird price for the diagnostic test if the indication is of the secondresult. In some embodiments, the second price is a recurring payment andthe third price is a one-time payment. In some embodiments, the secondprice is associated with a cost of a therapeutic treatment. In someembodiments, the second price is associated with a recurring cost of atherapeutic treatment. In some embodiments, one of the second price andthe third price is zero.

In some embodiments, the first result indicates a disease state and thesecond result indicates a non-disease state. In some embodiments, thefirst result indicates that a therapeutic treatment is desirable and thesecond result indicates that the therapeutic treatment is not desirable.In some embodiments, the method also includes selecting a therapeutictreatment based on the indication if the indication is of the secondresult, and delaying the charging of the second price until thetherapeutic treatment has provided a useful result.

In one embodiment, a method of distributing a diagnostic test includesproviding the diagnostic test to a first party, collecting a first costbased on the result of the diagnostic test, and providing a portion ofthe first cost to a second party. In some embodiments, the first partyeffects administration of the diagnostic test to an individual. In someembodiments, the first cost is collected from the first party. In someembodiments, the first cost is collected from a party other than thefirst party.

In some embodiments, a second cost is collected from a party other thanthe first party, and a portion of the second cost is provided to thesecond party. In some embodiments, the diagnostic test is received fromthe second party at a second cost before the diagnostic test is providedto the first party. In some embodiments, the second cost is determinedbased on an economic value of a possible or expected result of thediagnostic test.

While certain embodiments have been shown and described above, variouschanges in form and details may be made. For example, some features ofembodiments that have been described in relation to a particularembodiment or process can be useful in other embodiments. Someembodiments that have been described as methods can be implemented assoftware or as digital or analog hardware. Additionally, althoughmethods and apparatus described herein have been described withreference to medical diagnostics, the methods of pricing describedherein can be applied to pharmaceutical drugs, or other medical servicesand/or devices. Particularly when an outcome or result of suchpharmaceutical drugs and medical services and/or devices can be measuredor determined. For example, a drug or medical device is prescribed andgiven for a low/minimal initial price, and upon successful remedy of thecondition or disease being treated, a higher or additional price istriggered or charged. Furthermore, although methods and apparatusdescribed herein have been described with reference to manufacturers,these methods and apparatus can be equally applicable to distributorsand/or other entities other than manufactures that provide medicaldiagnostics.

It should be understood that the systems and methods described hereincan include various combinations and/or sub-combinations of thecomponents and/or features of the different embodiments described. Forexample, steps and aspects of one process described herein can becombined with steps and aspects of one or more other processes describedhere. Thus, features described with reference to one or more embodimentscan be combined with other embodiments described herein.

What is claimed is:
 1. A method of pricing a diagnostic testadministered to a test subject, comprising: receiving data associatedwith the diagnostic test, the data including an indication of one of afirst result of the diagnostic test and a second result of thediagnostic test; and setting a price of the diagnostic test based on theindication.
 2. The method of claim 1, further comprising charging arecurring payment for the diagnostic test based on the price.
 3. Themethod of claim 1, wherein the price is greater if the indication is ofthe first result than the price if the indication is of the secondresult.
 4. The method of claim 1, wherein the price is at least onehundred times greater if the indication is of the first result than theprice if the indication is of the second result.
 5. The method of claim1, further comprising determining a value associated with theindication.
 6. The method of claim 1, wherein the first result indicatesthe presence of a disease and the second result indicates the absence ofthe disease.
 7. The method of claim 1, wherein the first resultindicates that a therapeutic treatment is desirable and the secondresult indicates that the therapeutic treatment is not desirable.
 8. Themethod of claim 1, wherein the setting includes setting the price basedat least in part on a recurring cost of a therapeutic treatmentassociated with the indication.
 9. The method of claim 1, wherein theprice is zero if the indication is of the second result.
 10. The methodof claim 1, wherein the price is variable over time and based on theoutcome of a therapeutic treatment.
 11. The method of claim 1, wherein:the setting a price of the diagnostic includes accessing a data set at adatabase, the data set associated with one of the first result of thediagnostic test and the second result of the diagnostic test.